Maliban Biscuit Manufactories Ltd.
⚠️ Moderate Risk
FEI: 3004394895 • Ratmalana, LK-11 • SRI LANKA
FEI Number
3004394895
Location
Ratmalana, LK-11
Country
SRI LANKAAddress
389 Galle Road, , Ratmalana, LK-11, Sri Lanka
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
LACKS N/C
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
YELLOW #5
The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.
USUAL NAME
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/4/2021 | 03CET03BISCUIT PREPARED DRY MIX WITHOUT MILK OR EGG | 11UNSAFE COL | Division of West Coast Imports (DWCI) |
| 4/5/2018 | 03CET03BISCUIT PREPARED DRY MIX WITHOUT MILK OR EGG | Division of West Coast Imports (DWCI) | |
| 5/4/2016 | 07AGT99BAKED SNACK FOOD, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 11/19/2014 | 03CGP03BISCUIT PREPARED DRY MIX WITHOUT MILK OR EGG | 11UNSAFE COL | Division of Northeast Imports (DNEI) |
| 2/8/2013 | 03CET03BISCUIT PREPARED DRY MIX WITHOUT MILK OR EGG | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 6/12/2012 | 03CHY03BISCUIT PREPARED DRY MIX WITHOUT MILK OR EGG | 11UNSAFE COL | Minneapolis District Office (MIN-DO) |
| 6/4/2012 | 03FEE02FLAVORED OR PARTY CRACKERS | Los Angeles District Office (LOS-DO) | |
| 6/4/2012 | 03HGT10CREME,PLAIN COOKIE, BISCUIT AND WAFER | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 1/5/2012 | 03HGT08BUTTER/BUTTER FLAVORED,PLAIN COOKIES,BISCUITS AND WAFERS | Baltimore District Office (BLT-DO) | |
| 6/10/2011 | 07AGT99BAKED SNACK FOOD, N.E.C. | Baltimore District Office (BLT-DO) | |
| 3/20/2010 | 03HGT01VANILLA PLAIN COOKIE,BISCUIT AND WAFER | Los Angeles District Office (LOS-DO) | |
| 3/20/2010 | 03HGT02CHOCOLATE PLAIN COOKIES,BISCUITS AND WAFERS | 218LIST INGRE | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Maliban Biscuit Manufactories Ltd.'s FDA import refusal history?
Maliban Biscuit Manufactories Ltd. (FEI: 3004394895) has 12 FDA import refusal record(s) in our database, spanning from 3/20/2010 to 10/4/2021.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Maliban Biscuit Manufactories Ltd.'s FEI number is 3004394895.
What types of violations has Maliban Biscuit Manufactories Ltd. received?
Maliban Biscuit Manufactories Ltd. has been cited for 7 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Maliban Biscuit Manufactories Ltd. come from?
All FDA import refusal data for Maliban Biscuit Manufactories Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.